NCT02981563

Brief Summary

The aim of this project is to test and evaluate a nursing intervention, Time Together (TT), created to enable quality interactions between patients and staff in psychiatric inpatient care. The research questions are: Does TT influence the quality of interactions between staff and patients? Does TT influence patients' levels of anxiety and depressive symptoms? Does TT influence staffs' levels of perceived stress and levels of stress of conscience? Does TT influence the prevalence of coercive measures, mean length of hospital stay and the use of PRN medication? In parallel, a process evaluation will be conducted, answering questions such as: How do staff and patients describe their experiences of the intervention and how do contextual factors influence the effects of the intervention? What are the relationship between the outcome variables and the degree of compliance with the intended intervention? What problems are there with recruitment and dropouts?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

December 1, 2016

Last Update Submit

October 24, 2017

Conditions

Mental Health NursingNurse-Patient Relations

Keywords

engagementpsychiatric in-patient caremental health nursingquality interactions

Outcome Measures

Primary Outcomes (2)

  • Quality of interactions [patients]

    This is measured using The Caring Professional Scale (CPS) that consists of 14 items answered on a 5-point Likert scale.

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  • Perceived stress [staff]

    PSS consists of 10 items answered on a 5-point Likert scale

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

Secondary Outcomes (7)

  • Global quality of interactions [patients, staff]

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  • Anxiety and depressive symptoms [patients]

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  • Stress of Conscience [staff]

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  • Quality of care [staff]

    Changes during baseline and intervention period (measured every seventh week day for a total of 16 weeks)

  • Number of PRN medications given

    Changes during baseline and intervention period (measured weekly for a total of 16 weeks)

  • +2 more secondary outcomes

Study Arms (1)

Time Together

EXPERIMENTAL

Time Together as described under "Interventions"

Other: Time Together

Interventions

Time TogetherOTHER

For a fixed time during the day, staff dedicates their time to exclusively engage with the patients. Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations. Other duties of more administrative nature, visits and meetings will be performed at other times during the day. Through this, opportunities for interaction are both created and protected.

Also known as: Protected Engagement Time
Time Together

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Admitted to the wards during either A phase, B phase and/or follow-up
  • Experience of at least one TT session is required to participate in the B phase

You may not qualify if:

  • \- Does not master the Swedish language well enough to complete questionnaires and participate in interviews.
  • \- Regularly employed at the ward during A and B phase and/or follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Molin J, Lindgren BM, Graneheim UH, Ringner A. Does 'Time Together' increase quality of interaction and decrease stress? A study protocol of a multisite nursing intervention in psychiatric inpatient care, using a mixed method approach. BMJ Open. 2017 Aug 28;7(8):e015677. doi: 10.1136/bmjopen-2016-015677.

    PMID: 28851774DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

November 1, 2017

Last Updated

October 26, 2017

Record last verified: 2016-11